Known Identifiers & Locations
FEI Numbers
3003481798
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0001-2018 |
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany.
The INTRABEAM System is indicated for radiation therapy treatments
Reason: The device had an incorrect printed calibration value on the calibration certificate.
|
2017-08-30 |
Terminated
|
View Details
|
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